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NEW YORK - HOOKIPA Pharma Inc. (NASDAQ: HOOK), a clinical-stage biopharmaceutical company, has announced the completion of enrollment for its Phase 1b clinical trial of HB-500, a therapeutic vaccine candidate for the treatment of human immunodeficiency virus (HIV). This milestone in the trial, which is being conducted in collaboration with Gilead Sciences, Inc. (NASDAQ:GILD) (Gilead), marks a significant step in the development of a potential component for a curative regimen for HIV.
The trial has enrolled 30 participants across five sites in the United States, focusing on the safety, tolerability, reactogenicity, and immunogenicity of repeated doses of HB-500 in individuals with HIV who are on suppressive antiretroviral treatment. The trial includes two dose escalation cohorts, with participants randomized to receive either HB-500 or a placebo.
HB-500 utilizes two genetically engineered replicating vectors based on arenaviruses to deliver HIV antigens, with the goal of inducing robust and durable immunity. The vaccine aims to cover more than 80% of circulating HIV-1 viral variants, potentially providing a significant breadth of protection.
Dr. Dan H. Barouch, a leading researcher in the field of vaccine and virology research, highlighted the vaccine’s design to drive viral suppression, durable immunity, and eradication of the pro-viral reservoir as key components in the strategy for a potential functional cure of HIV.
The first participant in the trial was dosed on July 1, 2024, and primary completion is expected in the second half of 2025. Following the completion of the Phase 1b trial, Gilead will have the exclusive right to further develop the program.
HOOKIPA’s development of HB-500 is part of a broader collaboration with Gilead that includes other therapies intended to provide functional cures for hepatitis B virus (HBV) and HIV-1. The company’s pipeline also features immunotherapeutics targeting various cancers and serious infectious diseases.
This announcement is based on a press release statement and provides a factual account of HOOKIPA’s progress in the development of HB-500 as a potential therapeutic vaccine for HIV. The information reflects the company’s ongoing efforts and the current state of the clinical trial without any endorsement of claims or potential outcomes.
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